pharmaphorum

MAY 7, 2021

UK-based Small Pharma has launched on the Toronto’s TSX Venture Exchange, raising 58 million Canadian dollars (around £34m) to develop medicines based on N,N-dimethyltriptylene (DMT) to treat depression. The goal of the trial is for proof of concept of the drug as a wrap-around therapy for Major Depressive Disorder.

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Outsourcing Pharma

APRIL 6, 2023

TWO US clinical investigator sites have been opened for a phase 1 clinical trial for patients with soft tissue sarcoma and the first patient has been dosed.

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Worldwide Clinical Trials

NOVEMBER 3, 2022

In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. Ansel said he’s seen an increase in the number of sponsors coming to Worldwide Clinical Trials for exactly that purpose. And it takes time to get right.

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pharmaphorum

JANUARY 19, 2021

A survey by rare disease patient network Raremark found that 86% of the community members asked were interested in taking part in clinical trials. CEO Jeremy Edwards looks at how decentralised trial models can solve some of the challenges for clinical trial recruitment in rare disease.

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Pharmaceutical Technology

SEPTEMBER 20, 2022

Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research. Finding the best clinical trial packaging services providers. Clinical trial packaging and labelling solutions.

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STAT News

MARCH 27, 2023

Food and Drug Administration proposed cancer drug developers in most cases conduct more rigorous trials to seek accelerated approval for their candidates , Reuters tells us. Meanwhile, we have been busy foraging for items of interest, which we hope will ease your journey today. We appreciate insightful tips.

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pharmaphorum

AUGUST 25, 2022

When cirrhosis complications develop, some will be lucky enough to be listed for a transplant. But herein lies the dichotomy that medicine has created: By failing to regularly screen to find the early-stage disease, the number of patients who could participate in drug trials is limited. Others are not so fortunate.

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pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

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Clinical Trials Clinical Trials Trials Clinical Research 111

XTalks

FEBRUARY 25, 2022

There has been increasing awareness around the need for improving inclusion and diversity in clinical trials. As such, there has been a growing emphasis on efforts to achieve better and more accurate representations of minority and underrepresented populations like Black people in clinical studies.

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Scienmag

JUNE 15, 2022

A novel staging framework that assesses the progression of Huntington’s disease (HD), similar to the way cancer is staged 0 to 4, has been developed by UCL scientists as part of an international consortium; this ‘significant’ step paves the way for clinical trials of drugs in the earliest phase of disease.

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XTalks

AUGUST 4, 2022

Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. The Diversity of the US Population.

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Clinical Trials Clinical Trials Trials Clinical Research 52

pharmaphorum

SEPTEMBER 27, 2021

As people have become more conscious and vocal about diversity and inclusion, Page & Page’s Lisa Lishman says pharma should reassess how it conducts clinical trials. The pharmaceutical industry is one of the most important industries in the world, providing lifesaving drugs and treatment to people who need it the most.

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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. These products will require clinical trial data to get to market, but with significantly fewer participants required as compared to a drug trial.

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pharmaphorum

MAY 14, 2021

China’s Kintor Pharmaceutical has begun late-stage US clinical development of its potential COVID drug proxalutamide – but there is scepticism over the company’s claims about its research. But Reuters reported that the doctor identified as its principal clinical trial investigator has said he is not in charge of the trial.

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pharmaphorum

OCTOBER 27, 2020

Collecting and analysing anonymised patient data has the potential to generate valuable insights that can catalyse research, lead to improved patient care, and power the development of new treatments. In trials for cardiovascular, HIV, kidney disease and digestive diseases, women have especially been underrepresented.

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pharmaphorum

AUGUST 6, 2020

.” Finding new medicines to treat schizophrenia has proved to be a tough task for Lundbeck – its share price cratered in late 2018 after another potential drug failed in a phase 3 trial. The post Lundbeck gets cold feet, axes schizophrenia drug trial appeared first on.

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Drug Trials Trials Drugs Development 52

XTalks

SEPTEMBER 13, 2024

Diverse clinical trials are a matter of equity and essential for the validity and reliability of research outcomes. Historically, racial and ethnically minoritized groups or populations have been excluded from clinical trials, leading to a lack of data on how different demographic subgroups respond to treatments.

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Trials Clinical Trials Clinical Trials Clinical Research 52

Scienmag

JULY 18, 2021

The models allow for virtual trials of drugs and vaccines, opening the possibility of pre-assessment for drug and vaccine efficacy against the virus. Researchers are using computer models to simulate COVID-19 infections on a cellular level – the basic structural level of the human body.

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XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease. Malaria Vaccine Phase II Trial.

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VirTrial

MAY 26, 2020

Scottsdale, AZ (May 26, 2020) – VirTrial today announced a new service designed to enable virtual site monitoring visits in the clinical trials industry. VirTrial is a bioscience technology company providing a stable, long-standing telemedicine platform to transform the clinical trial industry.

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Delveinsight

AUGUST 12, 2021

Through its development and use of different algorithms, Zebra Medical has been able to recognize visual symptoms for diseases such as breast cancer , osteoporosis , and fatty liver , as well as conditions such as aneurysms and brain bleeds. The original agreement had Finch responsible for early-stage development through phase 2 studies.

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Trials Clinical Trials Clinical Trials Development 97

Advarra

JUNE 27, 2023

Clinical trials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. The goal is to identify safer, more effective methods of treating illnesses using new drugs or new combinations of existing drugs.

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Clinical Research Research Clinical Trials Clinical Trials 52

Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. FDA Expedited Programs.

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FDA Law Blog

MAY 3, 2021

On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a). 42 U.S.C. §

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Clinical Trials Clinical Trials Trials Regulation 52

Pharmaceutical Technology

SEPTEMBER 7, 2022

Before drugs are authorised, evidence of their safety and efficacy is limited to results from clinical trials, so it is essential that pharmacovigilance continues after a therapy has been approved. After AEs are recorded, they must be translated and put back out to doctors and scientists for processing.

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The Pharma Data

NOVEMBER 10, 2020

Biomarkers will be critical to developing precision medicine for Alzheimer’s disease. Although a few are out there, phosphorylated tau (P-tau) may enable even earlier and more accurate detection, according to Eli Lilly-associated researchers speaking at the Clinical Trials on Alzheimer’s Disease (CTAD) virtual conference in early November.

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Clinical Trials Clinical Trials Trials Antibody 52

Crucial Data Soutions

FEBRUARY 24, 2020

(CDS), a leading technology provider focused on data collection and clinical trial management, today announced several updates in celebration of its tenth anniversary, including the company’s latest technological development, TrialKit AI, a machine-learning API. About Crucial Data Solutions.

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FDA Law Blog

MAY 3, 2021

Butler — On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a). 42 U.S.C. §

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Clinical Trials Clinical Trials Trials Regulation 40

Placebo Control

DECEMBER 4, 2013

Instead of looking at registered trials and following them through to publication, this study starts with a random sample of phase 3 and 4 drug trials that already had results posted on ClinicalTrials.gov - so in one, very obvious sense, none of the trials in this study went unpublished.

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Trials Clinical Trials Clinical Trials Containment 40

World of DTC Marketing

JULY 19, 2021

CDC and new drugs have fostered an era of mistrust with some people. DTC marketers need to be more forthcoming when it comes to drug trials and side effects. Besides the blatant misinformation, most issues revolve around long-term safety as people feel the vaccine was developed too quickly.

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pharmaphorum

FEBRUARY 4, 2022

Last year, Bayer launched a project to explore the use of artificial intelligence in clinical trials, working with Finland’s Aalto University to find ways to use the technology to support decentralised trials and streamline the testing process.

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XTalks

OCTOBER 7, 2024

Takeda has forecasted continued financial pressure but is banking on new drug trials to stabilize its position​. Clinical t rial f ailures: Amylyx’s large-scale layoffs underscore the heavy dependence some companies have on a single product.

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ACRP blog

DECEMBER 18, 2024

Medical device trials, however, are typically smaller in scale and require fewer phases [than drug trials]. The information from this site goes on to describe how medical device studies are divided into three different classes, rather than into the familiar phases of drug studies.

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Pharmaceutical Technology

APRIL 27, 2023

The successful development and deployment of the mRNA-based COVID-19 vaccines has catalysed the biopharma industry and paved the way to expand this drug modality to new therapeutic areas. Excluding vaccines, there are five mRNA therapeutic products in clinical trial development as of November 2022. billion by 2028.

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The Pharma Data

MAY 17, 2021

Regeneron resumes enrollment in lymphoma drug trials ( Reuters ). Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ). China backs developing countries’ call to waive IP rights on COVID-19 vaccines ( Reuters ). Now they fear an increase.

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